The unbearable cost of pharmacovigilance

“Making more informed drug choices using comprehensive and actionable adverse drug events data leads to improved patient safety and outcomes and reduced costs.” Becker’s Hospital Review, 2015 According to Institute of Medicine (IoM) study To Err Is Human (IoM, 2007), adverse drug events are the largest single category of adverse events in hospitalized patients that account for 19% of all injuries. According to this study, the number of preventable adverse drug events that occur annually in U.S. hospitals ranges from

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Drug diversion – issues and identification

Section 505-1 of the FDCA authorizes FDA to require the submission of a risk evaluation and mitigation strategy (REMS) if FDA determines that such a strategy is necessary to ensure that the benefits of the drug outweigh the risks. Spotting drug diversion within the current reporting system is a major challenge due to limited information on the offending product. Close surveillance of drugs that could be used criminally to immobilize victims is particularly crucial. Drug-facilitated sexual assault (DFSA) is a

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Biases in pharmacovigilance reporting

The FDA Adverse Event Reporting System (FAERS) database is often taken as the “gold standard’ to which data gathered from social media is compared. This practice, although useful in a practical sense, has some limitations that need to be considered. Disproportionality calculations rely on comparator incidence as a valid and reliable control. The use of FAERS as the gold standard in social media monitoring The database is meant to support the post-market surveillance efforts and contains information on adverse events,

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Detection and annotation of data from social media

Manual annotation of vast amounts of data obtained from social media is a costly commitment because the work must be done by experts with domain knowledge. The amount of data required to train the algorithm is in the tens of thousands of records. Extraction of ADRs from generic platforms such as Twitter is more difficult than from platforms that are highly specialized. Twitter users generate over 400 million posts daily, of which most have no relevance in drug safety. According

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Twitter and Facebook as a source of pharmacovigilance data

Social media use has substantially expanded over the last decade, with 321 million monthly users and 126 million daily users on Twitter. This year, Twitter made a few tweaks to its own user metric: instead of daily users, they count monetizable daily active users. This figure might not be directly comparable to other social networks such as Instagram (500 million daily users) and Snapchat (186 million daily users). Because Twitter cracked down on bots, fake profiles, and spam users, its

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Quality of evidence in pharmacovigilance

Database WITHDRAWN lists 578 drugs that were pulled out of global markets due to safety reasons. Most importantly, the database contains information about therapeutic targets, off-targets, underlying mechanisms of toxicity involved, and biological pathways. In addition, the database maps single nucleotide polymorphism (SNPs), genetic variations that are associated with toxicity in some people [1]. Post-market safety withdrawals occur for a variety of reasons, from lack of efficacy to manufacturing and business reasons. Yet, for approximately half of the drugs in

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The right drug at the right dose to the right patient: the value of pharmacogenomic information

In April 2019, Mozilla internet health report published an article “23 reasons not to reveal your DNA” [1]. The primary reasons why people should worry about sharing their DNA with strangers are quite obvious – privacy concerns, the potential for abuse and limited validity of the findings top the report’s list of reasons. While there are good motives why one should stay away from universal wavers that allow the use of DNA for research by third parties, such judgment is

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Social media as a source of adverse drug effects

People increasingly turn to online sources to search for health-related information, investigate options they have, and only then decide whether it is worth investing time and money to get the qualified opinion of a healthcare professional. Pew Research Center asked U.S. adults about their behavior online when it comes to health-related questions. The results were astonishing: 35% of U.S. adults went online to figure out a medical condition they or people around them might have. Of these online diagnosers, 46%

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Digital epidemiology in pharmacovigilance

One of the most important shortcomings of the current pharmacovigilance data collection system is the fact that the FDA Adverse Drug Event Reporting System (FAERS) does not provide any insight into the incidence, prevalence, and rates of occurrence of adverse drug events in the post-approval period [1]. To improve the ability to detect trends and rates, data collection systems need to be modified to incorporate less traditional data points. The utilization of patient-generated data such as search engine logs, social

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Pharmacovigilance at a crossroads

The global pharmacovigilance market is growing and is still expected to grow. In 2013, post-market safety surveillance accounted for 60% of the global pharmacovigilance market and should reach $6 billion by 2020. Main drivers for increased reporting of adverse drug reactions include compliance requirements and liability resulting from high-profile product failures. Implementation of a reporting system to comply with regulatory requirements for a Phase I study can cost about $100,000, before the first serious adverse event (SAE) even occurs [1].

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